Batch Control (Human)
Allergens, products manufactured from blood plasma, immunoglobulins and vaccines are fundamentally subject to official batch release pursuant to section 32 of the Medicinal Products Act (AMG). In accordance with this, every manufactured batch of these medicinal products must be released by the Paul-Ehrlich-Institut (PEI) before being placed on the market in Germany.
For the release of a batch, the marketing authrisation holder must submit documents to the PEI regarding the manufacture of the batch, together with the results of all quality control tests carried out and test samples from the manufactured batch. If the inspection of the batch record and the experimental testing show that the batch corresponds to the criteria defined in the medicinal product’s marketing authorisation with regard to quality, efficacy and safety and that the batch has been manufactured and tested in accordance with the prevailing standard of scientific knowledge, the PEI will send the marketing authorisation holder a notice informing it of the release of the batch. This national release notice allows the marketing authorisation holder to market the batch in Germany.
The experimental testing for batch release in Germany may be conducted either by the PEI or by an official medicinal product control laboratory in another member state of the European Union (EU) or European Economic Area (EEA). The corresponding regulations are explained in the section on experimental testing.
Information regarding batch release of parallel imported/distributed medicinal products is provided here.
Furthermore, the PEI carries out experimental testing of medicinal product batches that are intended for marketing outside Germany and issues appropriate certificates.
Exemption from official batch release in accordance with section 32 sub-section 4 AMG is possible if the manufacturing and test methods of the manufacturer have reached a level of development which guarantees the quality, efficacy and safety required.